IEC 60601-1-9: Requirements for Environmentally Conscious Design

Verify your Medical Equipment meets IEC 60601-1-9 standards on Environmentally Conscious Design

More than 80 percent of hospitals around the globe are expected to incorporate sustainability into the purchasing decisions, according to a Harris Poll commissioned by Johnson & Johnson. National and international bodies, including Brazil which mandates regulatory compliance with a number of IEC 60601-1-9 clauses, are increasingly emphasizing healthcare’s role in promoting eco-friendly products to encourage human and environmental health.

What is IEC 60601-1-9?

IEC 60601-1-9 focuses on environmentally conscious design and development of medical electrical equipment to minimize environmental impact throughout the device's lifecycle. It emphasizes sustainable practices such as energy efficiency, reducing the use of hazardous materials, and minimizing waste during manufacturing, usage, and disposal. The standard requires manufacturers to evaluate the environmental impact of raw materials, production, distribution, and end-of-life processes, encouraging recycling and reusability. Additionally, it mandates the creation of an Environmental Management Plan (EMP) to document measures taken to reduce the device’s ecological footprint. By promoting compliance with global environmental frameworks like ISO 14001, IEC 60601-1-9 supports the development of safer, more sustainable medical devices.

Purpose of IEC 60601-1-9

The goal of IEC 60601-1-9 is to encourage manufacturers to adopt sustainable practices and create devices that are safe for patients while being environmentally responsible. It ensures medical devices not only meet clinical needs but also contribute to reducing the healthcare sector’s environmental footprint.

Intertek can help you demonstrate compliance to IEC 60601-1-9 by providing an engineering review of product design and development processes in line with the IEC 60601-1-9 standard on environmentally conscious design which will help manufacturers make important sustainability claims.